Comparing Post-operative Analgesic Effectiveness of Wound Infiltration Using Bupivacaine, Tramadol, and Tramadol Plus Bupivacaine in Patients Undergoing Elective Cesarean Section Under Spinal Anesthesia at Dessie Comprehensive Specialized Hospital, Ethiopia 2022 a Double-Blinded Control Study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Measuring pain severity
研究概览
简要总结
The goal of this study's clinical trial is to compare in post-operative analgesic effectiveness of wound infiltration using bupivacaine, tramadol, and tramadol plus bupivacaine in patients undergoing elective cesarean section under spinal anesthesia. The main question the study aimed to answer is "which approach is best among the 3"
all participants need to respond to the pain severity for the data collectors and they will receive treatments accordingly There will be 3 groups in the study
- group T: for tramadol
- group B: for bupivacaine
- group TB : tramadol + bupivacaine
详细描述
Source Population: All parturients who are scheduled for elective cesarean delivery under spinal anesthesia at Dessie Comprehensive Specialized Hospital
Sample size determination: since there is no previous study done with this title in the study area, we take from a previous study done by Sahmeddini et al in India in the same population. We choose the "time for the first request of analgesia" variable because we found a larger sample size with this variable using the G*Power application. Using G*Power (using version 3.1.9.2) with a power of 80% and confidence interval of 95%, we estimated 153 participants, and considering dropout and nonresponse (10% contingency) a total of 163 patients (54 in each group) would be needed.
Sampling procedure
A 5-month logbook report of the hospital showed that around 400 patients undergo elective c/s. 163 patients will be recruited with a probability of 24% until the sample size is achieved by considering the sequential patients scheduled for C/S as the sampling frame. All patients have a 50% equal chance of being included in the study. The first patient will be recruited by lottery method and then every 2nd will be included until the required sample size is completed. After informed consent is taken, eligible participants will be allocated to one of the two groups with a sealed non-transparent envelope containing the name of the study group
Data collection procedure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The data collector and the investigator will be blind for the study while the patient is not.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women age between 18 and 35
- •ASA risk class I-II
排除标准
- •- Chronic pain diagnosis
- •ASA above II
- •Comorbidities (Anemia, DM, HTN, Arthritis)
- •Known allergy to bupivacaine, tramadol
- •History of alcohol, opiate, or other drug abuse
- •Use of preoperative anti-pain
研究组 & 干预措施
Tramadol (T) group
Participants will be infiltrated with only 200mg tramadol around the wound.
干预措施: bupivacain-tramadol (Drug)
Bupivacain (B) group
participants will be infiltrated with only bupivacaine around the wound
干预措施: bupivacain-tramadol (Drug)
Tramadol + bupivacain ( T+B) group
The participants will be infiltrated with tramadol and bupivacaine which are mixed together in the same syringe.
干预措施: bupivacain-tramadol (Drug)
结局指标
主要结局
Measuring pain severity
时间窗: starting from discharging from operation table to the 2nd day of surgery ( for 48 hours)
Pain severity is measured by a visual analog scale(VAS) which measures pain severity from zero to ten
次要结局
未报告次要终点
研究者
Aynalem Befkadu Woldemichael
Quality control coordinater, Research team leader, lecturer in anesthesia
Wollo University